NCT04364139

African American Study of Kidney Disease and Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,094 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The AASK is a multicenter, randomized, controlled clinical trial using a 2 × 3 factorial design to evaluate the effects of level of blood pressure control and type of anti-hypertensive medication on progression of chronic renal disease among African American men and women with chronic renal insufficiency caused by hypertension (hypertensive nephrosclerosis).

Detailed description

The AASK is a multicenter, randomized, controlled clinical trial using a 2 × 3 factorial design to evaluate the effects of level of blood pressure control and type of anti-hypertensive medication on progression of chronic renal disease among African American men and women with chronic renal insufficiency caused by hypertension (hypertensive nephrosclerosis). Two levels of blood pressure control were defined in terms of mean arterial pressure (MAP = 2/3 diastolic blood pressure + 1/3 systolic blood pressure). A usual goal is defined as an MAP of 102 to 107 mm Hg, and a low goal is defined as an MAP of 92 mm Hg or less. The three antihypertensive drug regimens contained either a calcium channel blocker (amlodipine), β-blocker (metoprolol; Toprol XL), or angiotensin-converting enzyme inhibitor (ramipril) as initial therapy. Progression of renal disease was measured as the rate of decline in glomerular filtration rate (GFR).

Conditions

• Hypertensive Nephrosclerosis
• Chronic Renal Insufficiency

Interventions

Type	Name	Description
OTHER	MAP goal less than or equal to 92 mm Hg	Lower Blood Pressure Goal (mean arterial pressure (MAP) less than or equal to 92 mm Hg) which corresponds to a BP of approximately 115/80 mmHg
OTHER	MAP goal 102-107 mm Hg	Usual Blood Pressure Goal (mean arterial pressure (MAP) 102-107 mm Hg) which corresponds to a BP of approximately 135/85 to 140/90 mmHg
DRUG	Ramipril	An angiotensin-converting enzyme inhibitor, (ACEI: ramipril) 2.5 to 10 mg/d
DRUG	Amlodipine	A dihydropyridine calcium channel blocker, (DHPCCB: amlodipine) 5 to 10 mg/d
DRUG	Metoprolol	A sustained release beta-blocker, (BB: metoprolol) 50 to 200 mg/d

Timeline

• Start date: 1995-02-01
• Primary completion: 2001-09-30
• Completion: 2007-06-30
• First posted: 2020-04-27
• Last updated: 2020-04-27

Regulatory

• FDA-regulated drug study